Keep Informed on Legal and Compliance Developments Affecting Diagnostic Labs
Best practices and expert insight to help lab professionals comply with regulations and identify strategic trends in business and technology
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Struggling with Staying Informed? In the fast-paced world of diagnostic medicine, staying updated with the latest legal, compliance, regulatory, and industry insights is crucial. Yet, finding reliable and comprehensive information can be overwhelming and time-consuming.
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Analysis and insight on key compliance, legal, and business developments affecting laboratories
- Updates on changes to regulations
- Healthcare-related laws
- FDA approvals
- Business deals in the diagnostics space, and more
Latest Articles
New FDA LDTs Guidance Offers Useful Summary, But Questions Remain
Recently released document for small labs offers a more digestible version of the final rule requirements but still lacks key details
Latest Major False Claims Act Settlement Involves 457 Hospitals in 43 States
By Kelly A. Briganti, Editorial Director, G2 Intelligence The Department of Justice (DOJ) announced last week another major settlement of False Claims Act allegations, involving hundreds of providers. This time, it's 70 settlements with 457 hospitals across 43...
Growth in BRCA Testing Not Met With Recommended Use of Pretest Counseling
By Lori Solomon, Editor, Diagnostic Testing & Emerging Technologies Most U.S. women undergoing BRCA genetic testing do not receive recommended genetic counseling, according to a study published Oct. 1 in JAMA Oncology. The finding of wide variability in referral...
Millennium Settles False Claims Allegations for $256 Million
By Kelly A. Briganti, Editorial Director, G2 Intelligence Seeking a fresh start, Millennium Health (San Diego, Calif.) announced it has agreed to pay three different settlement amounts and is entering into a corporate integrity agreement with the Department of...
Commonwealth Laboratories and Quest Collaborate on Distribution of IBS test
By Ron Shinkman, Editor, Laboratory Industry Report Commonwealth Laboratories has entered into a distribution agreement with Quest Diagnostics regarding its test for irritable bowel syndrome (IBS). Under the terms of the deal, physicians will be able to order the...
Avoid IRS, DOL Scrutiny: Properly Characterize Independent Contractors and Employees
By Kelly A. Briganti, Editorial Director, G2 Intelligence For flexible staffing, it may be appealing to hire independent contractors. But make sure your arrangement is truly an independent contractor arrangement and not employment. Just the label you give it isn't...
33rd Annual Lab Institute Highlights Opportunities and Challenges Ahead for the Industry
By Kelly A. Briganti, Editorial Director, G2 Intelligence Throughout two and a half days on Capitol Hill, laboratory insiders debated and shared knowledge, insight and concerns about compliance issues, new business challenges and the latest regulatory changes...